Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

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Abstract

The regulation of pharmaceutical stability studies still lacks universally accepted techniques regarding the identification of out-of-trend data. Three methods have been suggested for identifying out-of-trend data in pharmaceutical stability studies: the regression control chart, the by-time-point method, and the slope control chart. In Part I of this article series, the regression control chart method is investigated, and an improved approach is suggested. The method is illustrated using realistic data. In Part II, the by-time-point method and the multivariate control chart method will be discussed.

Peer-Review Article
Submitted: March 22, 2017
Accepted: June 27, 2017

About the Authors

Máté Mihalovits is a PhD student, mihalovits@mail.bme.hu; and Sándor Kemény* is an emeritus professor, Tel.: +36 309936307, kemeny@mail.bme.hu, both at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering Hungary, 1111. Budapest, Műegyetem rakpart 3.

* To whom all correspondence should be addressed.

Article Details

Pharmaceutical Technology
Vol. 41, No. 11
November 2017
Pages: 46–53

Citation:

When referring to this article, please cite it as M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart," Pharmaceutical Technology 41 (11) 2017.